Biological navigation device

ABSTRACT

A biological navigation device that can be attached or integrated with an elongated tool, such as an endoscope, is disclosed. The device can be used for propulsive advance through a biological lumen. The device can anchor to the biological lumen. The device can subsequently or concurrently propel the endoscope and anchor the device to the biological lumen. Methods for using the same are also disclosed.

CROSS-REFERENCE TO REPLATED APPLICATIONS

The present application is a continuation of PCT Application No.PCT/US2009/041637, filed 24 Apr. 2009, which claims priority to U.S.Provisional Application No. 61/125,720, filed 27 Apr. 2008, both ofwhich are incorporated herein by reference in their entireties.

BACKGROUND OF THE INVENTION

1. Field of the Invention

Devices for propelling through and exploring luminal cavities aredisclosed. One such device example is an endoscope, which can be used toexplore body passages. Such passages typically include, but are notlimited to, the GI tract, the pulmonary and gynecological systems,urological tracts, and the coronary vasculature. Methods for use includeexploration of the upper GI tract, including the small intestine andexploration of the lower part of the GI tract, for example the largeintestine or colon.

2. Description of the Related Art

Colonoscopy is a diagnostic and sometimes therapeutic procedure used inthe prevention, diagnosis and treatment of colon cancer, among otherpathologies. With colonoscopy, polyps can be harvested before theymetastasize and spread. With regular colonoscopies, the incidence ofcolon cancer can be substantially reduced.

The anus can provide entry into the colon for a colonoscopy. The colonextends from the rectum to the cecum and has sigmoid, descending,transverse, and ascending portions. The sigmoid colon is the s-shapedportion of the colon between the descending colon and the rectum.

Colonoscopy typically involves the anal insertion of a semi-flexibleshaft. To typically navigate the colon, the forward few inches of tipare flexed or steered as the shaft is alternately pushed, pulled, andtwisted in a highly skill-based attempt to advance to the end of thecolon: the cecum. The medical professional imparts these motions inclose proximity to the anus, where the device enters. Tip flexure hastypically been accomplished by rotating wheels—one that controls cablesthat move the tip right-left, and one that controls cables that move thetip up-down.

Colonoscopes typically utilize various conduits or channels. Theconduits or channels often contain elements that enable vision (e.g.,fiber optics, CCD cameras, CMOS camera chips) and lighting (e.g., fiberoptic light sources, high power LEDs (Light Emitting Diodes)), such asenergy delivery and/or receipt conduits. They have conduits that providesuction or pressurization, fluid irrigation, the delivery of instruments(e.g., for cutting, coagulation, polyp removal, tissue sampling) andlens cleaning elements (typically a right angle orifice that exits nearthe camera, such that a fluid flush provides a cleansing wash).

Colonoscopes include articulating sections at their tip, which allow theuser to position the tip. These articulating sections have rigid linkbodies that rotate relative to each other through the use of pins attheir connecting joints. As tensile cables pull from the periphery ofthe articulating sections, they impart torques, which rotate the linksections on their pins, articulating the tip section. The links areusually rotated by two or four tensile cables.

Typical commercially available colonoscopes are currently reusable.However, as disposable and other lower-cost colonoscopes are developed,these articulatable sections are no longer practical. Their high partcount creates total costs that are exorbitant for a lower cost,disposable device. The pivot pins can also fall out, which can create apatient danger. Their design geometries, while suited for long life,high cost, high strength metals elements, do not readily suit themselvesto the design goals of lower-cost and more readily mass-produced parts.

Suction can be utilized to remove debris or fluid. The colon can bepressurized to expand the diameter of the colon to enhancevisualization.

During advancement of the colonoscope through the colon, landmarks arenoted and an attempt is made to visualize a significant portion of thecolon's inside wall. Therapeutic actions can occur at any time, but aretypically performed during withdrawal.

Navigating the long, small diameter colonoscope shaft in compressionthrough the colon—a circuitous route with highly irregular anatomy—canbe very difficult. Studies have shown a learning curve for doctorsperforming colonoscopies of greater than two-hundred cases. Even withthe achievement of such a practice milestone, the cecum is often notreached, thereby denying the patient the potential for a full diagnosis.

During colonoscopy, significant patient pain can result. This istypically not the result of colon wall contact or of anal entry. Theprimary cause of pain is thought to be stretching and gross distortionof the mesocolon (the mesentery that attaches the colon to otherinternal organs). This is commonly referred to as ‘looping’ and is aresult of trying to push a long, small diameter shaft in compression asthe clinician attempts to navigate a torturous colon. While attemptingto advance the tip by pushing on the scope, often all that occurs isthat intermediate locations are significantly stretched and grosslydistorted. Due to this pain, various forms of anesthesia are typicallygiven to the patient. Anesthesia delivery results in the direct cost ofthe anesthesia, the cost to professionally administer the anesthesia,the costs associated with the capital equipment and its facilitylayouts, and the costs associated with longer procedure time (e.g.,preparation, aesthesia administration, post-procedure monitoring, andthe need to have someone else drive the patient home). It has beenestimated that forty percent of the cost of a colonoscopy can beattributed to the procedure's need for anesthesia.

Cleaning of colonoscopes is also an issue. Cleaning is time consuming,and lack of proper cleaning can result in disease transmission. Cleaningcan utilize noxious chemicals and requires back-up scopes (some in usewhile others being cleaned). Cleaning also creates significantwear-and-tear of the device, which can lead to the need for moreservicing.

In recent years there have been advancements in the navigation of thesmall intestine. One notable method is known as Double BalloonEnteroscopy. Double-balloon enteroscopy, also known as push-and-pullenteroscopy is an endoscopic technique for visualization of the smallbowel. It allows for the entire gastrointestinal tract to be visualizedin real time. The technique involves the use of a balloon at the end ofa special enteroscope camera and an overtube, which is a tube that fitsover the endoscope, and which is also fitted with a balloon. Theprocedure is usually done under general anesthesia, but may be done withthe use of conscious sedation. The enteroscope and overtube are insertedthrough the mouth and passed in conventional fashion (that is, as withgastroscopy) into the small bowel. Following this, the endoscope isadvanced a small distance in front of the overtube and the balloon atthe end is inflated. Using the assistance of friction at the interfaceof the enteroscope and intestinal wall, the small bowel is accordionedback to the overtube. The overtube balloon is then deployed, and theenteroscope balloon is deflated. The process is then continued until theentire small bowel is visualized. The double-balloon enteroscope canalso be passed in retrograde fashion, through the colon and into theileum to visualize the end of the small bowel.

Though the procedure has played a vital role in the diagnosis andtreatment of disease in this part of the GI tract, it remainsproblematic in several regards. Like colonoscopy, it suffers fromlooping. A long and flexible shaft is pushed, but instead of the tipmoving forward, it often merely moves inadvertently in intermediatelocations. The procedure requires significant skill, is laborious andtime consuming—usually taking more than an hour.

In both colonoscopy and in navigation of the small intestine, it wouldbe advantageous to have a device that enabled local ‘pull’ motion, i.e.,if the device could pull itself forward locally, rather than having tobe pushed at a far proximal and less effective location.

Methods have been suggested which create a force reaction locationoutside of the body. Others have been suggested which create a forcereaction location—necessary to advance the endoscope—within the body,including local to the endoscope tip. Internal devices typically operateproximal to the tip's articulating section, which can be kinematicallydisadvantageous relative to being located distal to the articulatingsection.

Endoscopic devices have found it notably challenging to create methodsto appropriately navigate through torturous geometries, particularlywithout undue colon wall stresses and subsequent mesocolon stretch.Steering kinematics are critical and have been an ongoingchallenge—certainly for existing colonoscopes (which result in‘looping’), but also to more effective next-generation devices.

The systems proposed to-date have geometries that create suboptimalsteering efficacies. When a propulsion element is substantially distalto the tip articulating section, it can be vectored in that directionwhen propelled. This can be highly advantageous relative to systems inwhich the propulsive element is located proximal to the articulatingsection. In this situation, disadvantageous kinematics are created whenthe tip is retroflexed and is pointing in one desired direction ofadvance and the system advance is attempted. The system does not move inthe direction of the retroflexed tip, but rather in the direction of thesystem proximal to that section. When the system is coaxial, thesedirections are the same. However, should the tip be retroflexed back 180degrees, the desired advance direction (i.e., tip pointing direction)and actual advance direction are 180 degrees apart. The driven sectionpresumes a vector—typically an axial manner—with the steering tip onlyhaving efficacy as it relates to its interaction with luminal walls. Inendoscopy, this wall interaction is undesirable—it creates unnecessarywall stress and trauma, and can be a significant contributor to grosswall distortion, known as looping. It would therefore be desirable tohave system designs that enable more lumen-centric steering that canpoint the articulating section in a direction and move in that pointeddirection as the unit is advanced through the colon's straights andcurvatures.

Such kinematic enablement could be achieved through a novel, dedicatedsystem. Alternatively, it could be enabled through a device that workedadditive to existing endoscopes. This would be advantageous, in that itwould utilize a vast installed base of advanced hardware, software, andtraining. Such ‘retrofit’ devices could potentially achieve scaledutilization in an accelerated manner.

Devices to achieve these performance goals will often have challengeswith optimal material selection. The desired structure can have a rarecombination of requisite features: softness, strength, radial stiffness,low thickness, freedom from leaks, flex-crack resistance, punctureresistance, appropriate coefficient of friction, the potential formodifiable geometry as a function of length, and appropriatemanufacturability and cost. Monolithic materials often proveinsufficient at providing the variety of requisite specifications.

BRIEF SUMMARY OF THE INVENTION

A device for navigation through a biological lumen is disclosed. Thedevice can have a propulsion device and an endoluminal tool. Theactuator can have an actuator outer wall and an actuator inner wall. Thepropulsion device can have an extendable actuator and an anchor, whereinthe actuator is distal to the anchor. The endoluminal tool can beattached to the actuator.

The actuator can have an actuator lumen extending through a distalterminal end of the actuator. The actuator lumen can be formed by theactuator inner wall. The actuator lumen can extend through the proximaland/or distal terminal ends of the actuator. The actuator lumen canextend through the entire actuator, opening at both terminal ends of theactuator.

The anchor can be radially expandable. The anchor can be inflatable. Theanchor can be or have a balloon.

The endoluminal tool can have a longitudinal axis. The actuator can beextendable along the longitudinal axis. The actuator can have anexpanded configuration and a retracted configuration. The outer diameterof the actuator in the expanded configuration can be substantially equalto the outer diameter of the actuator in the contracted configuration.

The actuator can be inflatable. The actuator can have one or morebellows. The bellows can have a hollow bellows lumen. The endoluminaltool can be positioned in the hollow bellows lumen.

The endoluminal tool can have or be an endoscope. The endoluminal toolcan have an articulation section. The anchor can be distal to thearticulating section of the endoluminal tool.

The actuator, for example the bellows, can have a fiber-reinforcedlaminate. The actuator can have a spring. The spring can be a helical ora leaf spring. The spring can have a circular or rectangular (e.g., asubstantially flat spring) cross-section of the coil of the spring.

A device for navigation through a biological lumen is also disclosedthat can have an endoluminal tool and a bladder defining an inflatableextendable volume. The bladder can be annular and define an inner lumenradially internal to, and not in fluid communication with, theinflatable extendable volume. The endoluminal tool can be located in theinner lumen. The distal end of the endoluminal tool can be mechanicallycoupled to the distal end of the distal end of the bladder, for example,via an attachment clamp distal to the bladder.

Also disclosed is a device for navigation through a biological lumenthat can have an endoluminal tool having an articulatible section, and abellows attached to the endoluminal tool distal to the articulatiblesection. The bellows can be annular. The bellows can form a bellowslumen. A length of the endoluminal tool can be located in the bellowslumen.

The bellows can longitudinally expand when inflated. The bellows canhave a substantially constant outer diameter in a deflated configurationwith respect to an inflated configuration. A urethane adhesive canattach a spring to the outer wall of the bellows.

Furthermore, a device for navigating through a biological lumen having apropulsion device having an actuator and an overtube, and an endoluminaltool is disclosed. The actuator can be distal to the overtube. Theendoluminal tool can be attached to the actuator.

A method for navigating through a biological lumen is also disclosed.The method can include attaching a distal end of a propulsion device toa distal end of an endoluminal tool and extending the actuator. Themethod can include pushing the overtube. Extending the actuator caninclude inflating the actuator. The method can include slidablytranslating the overtube with respect to the endoluminal tool. Theovertube can be directly or not directly attached to the endoluminaltool. The method can include clamping the propulsion device to theendoluminal tool.

A method is disclosed for navigating through a biological lumen havingan inner wall including inserting a device into the biological lumen,anchoring the device to the inner wall of the biological lumen, andextending the actuator. The device can have an actuator and an anchor,and the actuator can be distal to the anchor. The device can be attachedto an endoluminal tool extending proximal to the device.

Extending the actuator can include advancing the device along thebiological lumen. Extending the actuator can include deliveringpressurized fluid to the actuator and not exposing the endoluminal toolto the pressurized fluid.

BRIEF DESCRIPTION OF THE FIGURES

FIG. 1 is a schematic view of a variation of the device.

FIG. 2 is a schematic view of a variation of the device.

FIG. 3 is a schematic view of a variation of the base and a fluidsystem.

FIG. 4 illustrates a variation of the tip in a contracted or retractedconfiguration and a distal portion of the endoscope.

FIG. 5 illustrates a variation of the tip in a partially extendedconfiguration and a distal portion of the endoscope.

FIG. 6 illustrates a variation of the tip in an extended configurationand a distal portion of the endoscope.

FIG. 7 illustrates a variation of the tip in a contracted configurationand a distal portion of the endoscope.

FIGS. 8 a through 8 d illustrate variations of cross-section A-A of FIG.7.

FIGS. 9 and 10 illustrate a variation of the springs of the tip of FIG.8 b in contracted and expanded configurations, respectively.

FIGS. 11 a and 11 b illustrate a variation of the spring of the tip ofFIG. 8 b in contracted and expanded configurations, respectively.

FIG. 12 illustrates a variation of the bellow.

FIG. 13 is a variation of a length of cross-section B-B of FIG. 11 b.

FIG. 14 a and 14 b are variations of cross-section A-A of the support.

FIG. 15 illustrates a variation of the support.

FIG. 16 illustrates a variation of the anchoring balloon.

FIGS. 17 a through 17 g illustrate a variation of a method for using thedevice.

FIGS. 18 a and 18 c illustrate a variation of a method for using thedevice.

DETAILED DESCRIPTION

A biological navigation device 10 for navigation of passageways isdisclosed. The device 10 can be utilized for biological passageways. Thedevice 10 can have an endoscope 12 for navigating portions of the GItract. The scope 12 can be attached or integral with other elements toform an endoscopy system. The endoscopy system can continuously examineand/or treat the GI tract.

FIG. 1 illustrates that the device 10 can have a base 16, a propulsiontip 18, and one or more control lines 140 connecting the base 16 to thetip 18. The base 16 and tip 18 can be connected to the lines 140. Thetip 18 can have an anchor 20 and an actuator 22. The anchor 20 canreleasably attach to the wall of a biological lumen. The actuator 22 cancontrollably extend and retract in a longitudinal direction. The tip 18may fit over an endoluminal tool for navigating the body, such as anendoscope 12. The endoluminal tool can be a device for performingtherapeutic or diagnostic functions. The endoluminal tool can have atool or endoscope longitudinal axis 14. The tip 18 can be removably orfixedly attached to the endoluminal tool.

The control lines 140 can be fluid lines (i.e., for gas and/or liquid)and/or electrical or mechanical leads, such as conductive or mechanicalcontrol wires. The control lines 140 can transmit or carry pressurizedfluid (including negative pressure or vacuum), electrical signals andpower, and mechanical force to the tip 18, such as to the anchor 20and/or actuator 22.

The fluid pressure, electrical, or mechanical signals or power from thebase 16 can actuate the anchor 20 and/or the actuator 22.

FIG. 2 illustrates that the device 10 can have an overtube 24. Theovertube 24 may be positioned radially over the endoscope 12 or otherdevice for navigating the body. The overtube 24 can slidablytranslatable with respect to the endoluminal tool. The overtube 24 canbe not directly attached to the endoscope 12. The overtube can beattached to the actuator 22. The endoscope can be inside a lumen of theovertube 24. The overtube 24 may lead out of the patient's body. Theovertube 24 can be sufficiently axially rigid to maintain the actuator22 in a substantially controlled position along the length of abiological lumen during navigation of the lumen. The overtube 24 can besufficiently flexible to navigate a tortuous biological lumen, such as acolon. All or a length of the lines 140 can embedded in or slidably orfixedly attached to the overtube 24.

The overtube 24 can be made from a polymer such as polyvinylchloride(PVC), Santoprene, Nylon, low density polyethylene (LDPE). The overtube24 can have a durometer from about 70 shore A to about 80 shore A. Theovertube 24 can have an overtube outer diameter 26 from 10 mm to 15 mm.The overtube 24 can have an overtube inner diameter 28 from about 9 mmto about 13 mm. The overtube 24 can have an overtube thickness 30 fromabout 0.75 mm to about 3 mm, more narrowly from about 1 mm to about 1.5mm, for example about 1.2 mm. The overtube 24 can be a Fujinon TS-13140,TS-12140, or TS-13101 (from Fujinon Inc., Japan)

The device 10 can have no anchoring balloon 32 or can have one or moreanchoring balloons 32.

FIG. 3 shows a possible configuration for the base 16. The base 16 canhave or be in fluid communication with a fluid control system 124. Thebase 16, for example at the base pressure port 122, can be connected toa pressure delivery line 140. The pressure delivery line 140 can beconnected to an outgoing second valve 136 and/or an incoming first valve126.

The first valve 126 can be configured to open manually and/orautomatically. The first valve 126 can open when the tube pressureexceeds a maximum desired tube pressure. The first valve 126 can beconnected to a vacuum pump 128. The vacuum pump 128 can be activated todeflate the tube 12 and withdraw the tube 12 or reduce the tubepressure. The vacuum pump 128 can be attached to an exhaust tank and/ordirectly to a bleed or drain line 132. The exhaust tank 130 can beconnected to the drain line 132, for example to exhaust overflow fromthe exhaust tank 130.

Controls 134 can be in data communication with the first valve 126 andthe second valve 136. The controls 134 can be on the base 16 (e.g., abutton or switch on the base 16).

The second valve 136 can be attached to a pump 144, for example acylinder 146 with a displacement component 148, such as a piston. Apressure regulator 138 can be in the flow path between the pump 144 andthe second valve 136. The pressure regulator 138 and/or the first valve126 can open and release pressure from the pump 144 when the tubepressure exceeds a maximum desired tube pressure.

An intake tank 142 can be fed in line (as shown) or through the pump 144to the second valve 136, for example through the pressure regulator 138.The fluid in the intake tank 142 can be fed into the pressurized tube12. The intake tank 142 can have a fill line 150 for filling the intaketank 142 with fluid. The fill line 150 can be fed directly to the secondvalve 136, pressure regulator 138 or pump 144 without the intake tank142.

The biological navigation device 10 can have capital equipment which canprovide utility to the remainder of the device 10. The capital equipmentcan include, for example, the elements in the fluid control system 124.The fluid control system 124 can have a fluid source (e.g., the intaketank 142 and/or fill line 150), a pressurize source such as the pump144, a conduit for delivery of the pressurization media (e.g., thepressure delivery line 140), controls 134, system monitoring elements(e.g., can be in the controls 134). The capital equipment can reduce theprofile of the tube 12, for example, in which tools can be inserted. Theintegrated tools can create elements that reduce waste, thereby allowingfor higher value capture and less refuse.

The delivery line 140 can be attached to a handle 46 that attaches tothe tip 18 or the delivery line 140 can attach directly to the tip 18.

The fluid pressurization can be controlled by a variety of user inputs,for example a button on the endoscope, handle, tip 18 or base 16, voicecommands, foot pedals, or combinations thereof.

FIGS. 4 through 6 illustrate that the tip 18 can have increasinglyextended configurations. The anchor 20 can have one or more hooks,barbs, extendable fingers, or anchoring balloons 32. The actuator 22 canhave a controllably extendable element, such as one or more springs 36.The springs 36 can be in fluid permeable or fluid impermeable bellows34. The terminal distal end of the tip 18 can have a traumatic oratraumatic cap 40.

FIG. 4 illustrates that the anchoring balloon 32 can be partially orcompletely deflated and the actuator 22 retracted.

FIG. 5 illustrates that the anchoring balloon 32 can be partially orcompletely expanded, for example by inflating the balloon through fluidpressure delivered by a first line 140 a. The device 10 can have asecond line 140 b. The first line 140 a can transmit or carry signals,pressure, power, or combinations thereof between the base 16 and theanchor 20. The second line 140 b can transmit or carry signals,pressure, power, or combinations thereof between the base 16 and theactuator 22. The actuator 22 can be in a retracted or extendedconfiguration when the anchoring balloon 32 is expanding.

FIG. 6 illustrates that the anchoring balloon 32 can be in an expandedconfiguration and the actuator 22 can be extended, as shown by arrow.The actuator 22 can be activated by pressure, signals and/or power fromthe second line 140 b.

The actuator 22 can be expanded by the delivery of pressure throughsecond line 140 b. The second line 140 b can deliver a vacuum to theactuator 22 to produce a negative pressure within the fluid impermeablebellows 34 and retract the bellows 34 and the actuator 22. The bellows34 and/or the anchoring balloon 32 can have annular or toroidalconfigurations.

The first line 140 a can deliver positive pressure to the anchor 20 toactivate or inflate the anchoring balloon 32, and negative pressure orvacuum to contract the anchoring balloon 32.

The tip 18 and endoscope can be delivered into a biological lumen, suchas a colon, esophagus, or blood vessel. The anchoring balloon 32, forexample in an inflated configuration, can contact the wall of thebiological lumen. The balloon can exert a radial force and engageagainst the lumen wall, creating axial forces fixing or anchoring theanchor 20 to the lumen wall. The actuator 22 can then be expanded whilethe balloon remains substantially fixed against the lumen wall. Theendoscope can be slidably attached to the anchor 20, but fixedlyattached to the actuator 22. Hence, expansion of the actuator 22 whilethe balloon remains fixed against the lumen wall can advance theendoscope through the lumen, the endoscope can slide though the anchor20 and advance concurrent with the advancement of the actuator 22.

The balloon can expand at a low pressure for example minimizing forcesto the lumen wall. This expansion pressure of the balloon can be about 1psi. The balloon can be made from a very low durometer material, forexample a material that can stretch and contact the wall to a variety ofanatomies at a low pressure. Latex balloons can be utilized, along withother materials, including urethanes or other elastomers.

The anchoring balloon 32 can be made from a non-elastomeric orminimally-elastomeric material. The anchoring balloon 32 can have amaximum expanded diameter larger than the diameter of the lumen wallinto which the anchoring balloon 32 is to be delivered. The anchoringballoon 32 can be inflated to engage the wall without significantpressure or stretching of the anchoring balloon 32.

The actuator 22 and anchor 20 can be activated by pressure and/or vacuumfrom the base 16. The base 16 can be a pressure and a vacuum source. Thebase 16 can deliver a first pressure of about 30 psi to the actuator 22and/or anchor 20. The base 16 can deliver a second pressure, for exampleless than about 5 psi, for example about 1 psi or about 2 psi, to theactuator 22 and/or anchor 20 concurrent or subsequent to the delivery ofthe first pressure. The base 16 can be a stand alone unit, or part ofthe facility (e.g., hospital or health care office) pressure and vacuumsources.

These pressures and vacuum sources can be activated by user controls.User controls can be audible, foot-activated, or manually activated. Oneuser control can inflate the anchoring balloon 32. A second user controlcan expand (e.g., inflate) the actuator 22 may be inflated to drive theunit forward. The anchor 20 can be retracted by application of a vacuumfrom the base 16. The anchor 20 can be retracted before the bellowspressure is reduced, or the actuator 22 is otherwise retracted.

The anchoring inflation, actuator extension, anchoring deflation, andactuator retraction sequence can be repeated in sequence to advance theendoscope through a lumen. Sequential steps of inflation and contractioncan be automated. For instance, pressing a single button may triggerrepeated performance of the inflation, extension, deflation, retractionsequence to advance the endoscope.

FIG. 7 illustrates that the tip 18 can have an atraumatic cap 40 and thedistal terminal end of the tip 18. (The anchoring balloon 32 and theouter wall of the actuator 22 are not shown for illustrative purposes).The tip 18 can have a rigid anchor support 42. The anchor support 42 cansupport an anchor balloon 32. The anchor support 42 may have a conicalproximal entry, such as the entry funnel 44. The entry funnel 44 mayallow the proximal length of the endoscope exiting the entry funnel 44to articulate more freely within and adjacent to the entry funnel 44.The actuator 22 can have one or more springs.

The anchor support 42 can have first and second line connectors 46 a and46 b. The first and second line connectors 46 a and 46 b can connect tofirst and second lines 140 a and 140 b, respectively. The first andsecond line connectors 46 and 46 b can deliver fluid pressure, signalsand/or power between the lines 140 and the anchor 20 and actuator 22.

FIG. 8 a illustrates that the anchoring balloon 32 can have inflated andcollapsed (shown in phantom lines) configurations. The anchoring balloon32 may be mounted on the anchor support 42. The anchor support 42 mayencircle the endoscope in a support lumen 60. The anchor support 42 canblock the anchor balloon 32 from clamping to the endoscope or fromexposure to the pressure in the inflated anchor balloon 32. The anchorsupport 42 can have a balloon port 58 connecting flow to or from theline 140 from the line connector to the anchoring balloon 32 or actuator22.

The actuator 22 can have an actuating body 52. The actuating body 52 canbe expandable. The actuating body 52 can resilient or deformable. Theactuating body 52 can have one or more springs, foam, sponge,elastomeric tube, fluid-filled and/or gel-filled annular bladder,magnets, or combinations thereof. The device 10 can have no actuatingbody 52.

The actuator 22 can have an inner wall 50 a and/or an outer wall 50 b.The inner and/or outer walls 50 can be fluid impermeable. A fluid tight,or fluid-sealed, actuator chamber 48 or volume can be between the outerwall 50 b and the inner wall 50 a. The outer walls 50 b of the actuatorchamber 48 can form pleated bellows 34. The bellows 34 can be aninflatable bladder. The bellows 34 can form an annular shape. Thebellows 34 can form a bellows lumen 54 through which the endoscope canbe placed. The endoscope can be isolated from exposure to the pressurein the bellows 34. The bellows 34 can controllably expand along thedirection of the endoscopic longitudinal axis. The inner and/or outerdiameter of the bellows 34 in an expanded (e.g., inflated) configurationcan be substantially equal to the inner and/or outer diameter,respectively, of the bellows 34 in a retracted (e.g., deflated)configuration. The anchor support 42 can have an actuator port 70connecting the second line connector 46 b to the actuator chamber 48.

The inner wall 50 a and/or outer wall 50 b can be attached at points oralong the entire length of the actuating body 52. For example, the innerwall 50 a can be attached to the inner diameter of the actuator body 52and the outer wall 50 b can be attached to the outer diameter of theactuator body 52.

The anchor support 42 and/or the bellows 34 can have an annular shape.The endoscope may pass thru the inner lumen of the anchor support 42 andthe bellows 34.

The tip 18 may be placed distal to an articulating section on theendoscope. The tip 18 can be directionally oriented by the endoscope.The tip 18 can be partially or completely overlapping in length with thearticulate section of the endoscope.

The tip 18 can have a releasable attachment clamp 38. The attachmentclamp 38 can be clamped onto the distal end of the endoscope. The clampcan removably attach the actuator to the endoscope. The attachment clamp38 can interface with shear geometry in the endoscope. As the clampengages this shear groove in the scope, the clamp can couple forward andreverse motion of the bellows 34 to forward and reverse motion of theendoscope. The clamp can be a collet and/or split clamp and/or a snapring. The clamp can be made to interface with the endoscope without anyendoscope modification required.

The distal end of the endoscope can have an endoscope face. Theendoscope face can have exposed therapeutic and diagnostic instruments.The endoscope face can be exposed through a port in the cap 40 at thedistal end of the tip 18.

FIG. 8 b illustrates that the actuator body 52 can be one or moresprings 36. The actuator body 52 can have an inner spring 36 a and anouter spring 36 b. The outer diameter of the outer spring 36 b can beattached to the outer wall 50 b of the bellows 34. The inner diameter ofthe inner spring 36 a can be attached to the inner wall 50 a of thebellows 34.

The anchoring balloon 32 may be replaced or augmented by an overtube 24.FIG. 8 c illustrates that the anchoring balloon 32 has been replaced byan overtube 24. The overtube 24 may be a tube that encloses or partiallyencloses the endoscope 12. The overtube 24 may lead out of the body suchthat the physician can manipulate the tube. The overtube 24 may besufficiently rigid to provide a reaction force to the actuator. Theovertube 24 may be sufficiently flexible to be navigated thru the body.

FIG. 8 d illustrates that the device 10 can have a proximal anchoringballoon 32 a and a distal anchoring balloon 32 b (shown in an inflatedconfiguration in solid lines and a deflated configuration in phantomlines). The distal balloon 32 b can be attached to the cap 40. Thedistal balloon 32 b can be in fluid communication with a third line 140c through the cap 40.

The lines 140 can attach to the anchoring balloons 32 and actuatorchamber 48 through a connector and balloon port 58 as shown elsewhereherein. The first line 140 a can connect directly to the proximalballoon 32 a and/or to the proximal balloon 32 a via a direct connectorinto the proximal balloon 32 a. The third line 140 c can connect thebase 16 to the distal balloon 32 b. The third line 140 c can connectdirectly to the distal balloon 32 b and/or to the distal balloon 32 bvia a direct connector into the distal balloon 32 b. The second line 140b can connect directly to the actuator 22 and/or to the actuator 22 viaa direct connector into the actuator chamber 48. The lines 140 can be onthe radial outside or radial inside of the support and the bellows 34.

The distal and proximal anchoring balloons 32 a and 32 b can beactivated sequentially, concurrently, overlapping in time, orcombinations thereof. For example, the device 10 can be used byperforming the following, in the sequential order listed or anotherorder: inflate the proximal anchoring balloon 32 a anchoring theproximal balloon to the biological lumen; extend the actuator distallypulling the endoscope 12 distally with the distal end of the actuator(e.g., inflate the bellows 34); inflate the distal anchoring balloon 32b anchoring the distal anchoring balloon 32 b to the biological lumen;deflate the proximal anchoring balloon 32 a, retract the actuatorpulling the proximal anchoring balloon 32 a distally with the proximalend of the actuator (e.g., deflate the bellows 34); inflate the proximalanchoring balloon 32 a prior to, concurrent with or subsequent todeflating the distal balloon 32 b. When the anchoring balloons 32 areinflated, the anchoring balloons 32 can anchor to the wall of thebiological lumen. When the anchoring balloons 32 are deflated, theanchoring balloons 32 can release the anchoring to the wall of thebiological lumen.

FIG. 10 shows the inner spring 36 a can nest within the outer spring 36b. The springs 36 are shown retracted and extended. The bellows wall istypically coupled to the springs 36. The springs 36 provide a retractionor expansion force, in addition to the force provided by the vacuum orpositive pressure. By coupling the bellows wall to the springs 36, thebellows 34 expansion and contraction can be more controlled. The springs36 can be connected to the bellows 34 through sewing, pocketing,adhesion bonding, or combinations thereof.

FIGS. 9 and 10 illustrate that the outer and inner spring 36 a of theactuator can be configured to resiliently expand (as shown by arrow) orcontract in a relaxed state. The pressure applied to the bellows 34 toactivate the actuator can oppose the springs 36 to account for thedesired action. For example, if the springs 36 are contracted in arelaxed state, the bellows 34 can be inflated to expand the actuator.The pressure in the bellows 34 can be released and the springs 36 canretract the bellows 34 with or without negative pressure. Also forexample, if the springs 36 are expanded in a relaxed state, the bellows34 can be deflated to contract the actuator. The pressure in the bellows34 can be released and the springs 36 can expand the bellows 34 with orwithout positive pressure.

The bellows 34 may provide rapid, high-force actuation via hydraulicsand/or pneumatics. The bellows 34 can be annular to allow the tool orendoscope 12 to pass through their interior. This can be done with asingle bellows 34, or with an array of smaller (each individuallynon-annular) bellows 34. The bellows 34 can have a low-profile exteriorand an interior through which the endoscope 12 fits.

FIGS. 11 a and 11 b illustrate that the actuator body 52 can be one ormore flat springs 36. The spring can have an outer diameter of about0.92 in., an inner diameter of about 0.68 in., and a thickness of about0.014 in. The spring can be made of a spring metal, for example 17-4stainless steel. The spring can be made from a plastic. The crosssection of the coil of the spring can be rectangular.

FIG. 12 shows a bellows 34 separated from the tip 18. The bellows 34 mayhave a large extension ratio (compressed to expanded length), preferably1:10. The bellows 34 may have an annular shape with a clear passagethrough the device 10. The interior of the bellows 34 may be placed at apressure higher than the surrounding pressure. This may cause thebellows 34 to expand in length. The interior of the bellows 34 may beplaced at a pressure lower than the surrounding pressure. This may causethe bellows 34 to contract in length.

The bellows wall material can be very thin. For example, the thicknessof the bellows wall material can be from about 0.001 in. to about 0.002in. The bellows 34 can have a compression-to-extension ratio of about10:1 (i.e., a 0.5 in. contracted bellows 34 can expand to 5 in. at fullexpansion). The bellow wall material can be high strength to withstandpressure. The bellows wall material can have a low bending stiffness,high tensile strength and stiffness. The bellows wall material can bondwell to adhesives.

The bellows wall material can be or include a fiber-reinforced laminate,such as Cuben Fiber (from Cubic Tech Corp., Mesa, Ariz.). The bellowswall material can be a composite of a flexible, high shear strengthadhesive, engineering films, and high strength, small diameter fibers.The fibers can have a unidirectional orientation. The bellows wallmaterial can include fibers and cloths including those made from Kevlar,spectra, nylon, Dyneema, or combinations thereof. The fiber-basedelements can be deployed either as laminated unidirectional material, orwoven or knitted. The bellows wall material can have layers that can besewn together, bonded by wet adhesives or by heat activated elastomersor film adhesives.

The bellows 34 can have a bellows first end 62 a and a bellows secondend 62 b. The bellows ends 62 can be configured to fix to the adjacentelements when the device 10 is assembled. The bellows ends 62 can bereinforced. The bellows ends 62 can be attached to or integral with theinner wall 50 a and the outer wall 50 b to form a fluid-tight volume.

FIG. 13 illustrates that the inner or outer wall 50 b of the bellows 34can be a laminate 66. The wall can be bonded to the edge of the springwith adhesive 64. The spring can be a flat (as shown) or round spring.

The inner and/or outer wall 50 b of the bellows 34 can be bonded to athin urethane layer. The urethane layer can then be bonded to thespring, or the urethane can be pre-bonded to the spring. The urethanelayer can be, for example, about 0.001 in. to about 0.002 in. thick.

The adhesive 64 can have low stiffness and high strength. The adhesive64 can be heat deposited.

The adhesive 64 can be pre-deposited with the spring at a predeterminedpitch. Once the adhesive 64 is melted in place at this pitch, excessadhesive 64 can be cut, leaving a predetermined amount of adhesive 64 oneach of the coils, with a predetermined width and shear area.Subsequently, the inner laminate of the wall can be bonded to thissurface, now with sufficient area to resist debonding from the spring,and from the laminate 66.

FIG. 14A illustrates that the first line 140 a connector can be in fluidcommunication with the balloon port 58. The balloon port 58 can be influid communication with the anchoring balloon 32. FIG. 14B illustratesthat the second line connector 46 b can be in fluid communication withthe actuator port 70. The actuator port 70 can be in fluid communicationwith the actuator chamber 48 in the bellows 34.

FIG. 15 illustrates that the support can be flexible. The flexiblesupport may extend over the articulating section of an endoscope 12. Theflexible support may prevent the anchoring balloon 32 from clamping tothe endoscope 12. The flexible support may not hinder the ability of thenavigation device to steer. The flexible support may have an inflationpass-through line to connect pressure to the bellows 34 distal of theflexible support.

FIG. 16 illustrates that the anchoring balloon 32 may be toroidal inshape. The anchoring balloon 32 may or may not be fluid-tight orleak-tight.

FIGS. 17 a through 17 f illustrate advancing the endoscope 12 throughthe colon using the device 10.

FIG. 17 a illustrates that the biological navigation device 10 can bepositioned before entry into the colon 156, for example via the rectum160 after passing the anus 154. The endoscope 12 can be attached to theactuator 22 via the attachment clamp 38. For example, the endoscope 12can be delivered by a first manufacturer and the tip 18 can be deliveredby a second manufacturer, and the tip 18 can be attached to theendoscope 12 in a health care facility (e.g., hospital, doctor's office,clinic), for example by a technician or physician. The physician can usethe physician's desired tip 18 with the physician's desired endoscope12. The endoscope 12 does not need to be pre-attached to the tip 18 bythe manufacturer. The physician can select the optimal tip 18 andseparately select the optimal endoscope 12 shortly before the procedurebased on the patient's anatomy, health issues and procedure to beperformed.

FIG. 17 b illustrates that the device 10 can be delivered into therectum 160. The biological navigation device 10 can translate into therectum 160, attached to the elongated element 28. For example, initialdelivery of the device 10 into the rectum can be performed by insertingthe device 10 through the anus by hand.

The biological navigation device 10 is shown having an outer diametersmaller than the inner diameter of the colon 156 for exemplary purposes.The biological navigation device 10 can have an outer diameter aboutequal to the inner diameter of the colon 156. For example, the tip 18and/or endoscope 12 can substantially fill the cross-section of thelength of the colon 156 occupied by the tip 18 and/or endoscope 12.

Once positioned in the colon 156, the line 140 (or first line) candeliver pressure from a base 16 to the anchoring balloon 32. Theanchoring balloon 32 can expand, as shown by arrows. The anchoringballoon 32 can press against the inner wall of the colon, for example inthe rectum.

The line 140 can be fixedly or slidably attached along all or part ofthe length of the line 140 to the endoscope 12. For example, theendoscope 12 can have collars or a channel that can slidably or fixedlyattach to the line 140 as the line 140 extends distally away from thetip 18. The line 140 can be unattached to the endoscope 12 along theentire length of the line 140.

The endoscopic face 56 can be unobstructed by the cap 40. The one ormore tools or other elements in the endoscopic face 56 can diagnose andtreat during the delivery and advancement of the device 10 through thecolon.

FIG. 17 c illustrates that the actuator 22 can extend, as shown byarrow. For example, the line 140 (or second line) can deliverpressurized fluid from the base 16 to the bellows 34. The inflatedanchoring balloon 32 can induce a resistive force against the wall ofthe biological lumen to keep the anchoring balloon 32 substantiallystationary while the actuator 22 advances. The actuator 22 can beattached to the distal end of the endoscope 12. When the actuator 22advances, the endoscope 12 can advance. The line 140 can remainsubstantially stationary. The line 140 can slide against the side of, ina channel of, or within one or more collars on the endoscope 12 when theendoscope 12 longitudinally translates relative to the line 140.

FIG. 17 d illustrates that the anchoring balloon 32 can deflate orotherwise retract, as shown by arrows. The deflation of the anchoringballoon 32 can release the tip 18 from being anchored to the biologicallumen wall.

FIG. 17 e illustrates that the actuator 22 can retract, as shown byarrow. For example, the bellows 34 can be deflated through the line 140(or second line). When the actuator 22 retracts, the anchoring balloon32 can move toward the terminal distal end of the tip 18.

FIG. 17 f illustrates that the endoscope 12 can have an articulatablesection 68. The distal end of the endoscope 12 can be rotated, as shownby arrow, for example by the articulatable section 68. For example, thedirection the tip 18 is pointed can be steered for the distal end of thetip 18 to follow the center of the lumen of the colon or to point theendoscopic face 56 toward the wall (e.g., to inspect or treat a polyp).At any length in the colon 156, the biological navigation device 10,such as at the endoscopic face 56, can gather diagnostic (e.g., sensing)data, such as data for visualization, tissue inductance, RF absorptionor combinations thereof. At any length in the colon 156, such as at theendoscopic face 56, the biological navigation device 10 can also gathertissue samples (e.g., by performing a biopsy or removing a polyp). Atany length in the colon 156, such as at the endoscopic face 56, thebiological navigation device 10, can perform treatment or therapy, suchas delivery of a drug onto or into tissue, tissue removal (e.g., polypor tumor removal), or combinations thereof.

The method shown in FIGS. 17 b through 17 f can be repeated to steer andadvance the endoscopic face 56 to a desired location.

FIG. 17 g illustrates that the biological navigation device 10 can beadvanced along the entire colon 156, passing through the rectum 160,sigmoid colon 162, descending colon 164, transverse colon 166, ascendingcolon 168, and having the tip 18 in the cecum 170. The biologicalnavigation device 10 can be withdrawn, as shown by arrows, from thecolon 156, for example by applying a tensile force against the endoscope12, as shown by arrows 172 and/or by performing the reverse of themethod shown above (i.e., extend actuator 22, then inflate anchoringballoon 32, then retract actuator 22, then deflate anchoring balloon 32,then repeat as desired). The biological navigation device 10 can bewithdrawn, as shown by arrows, from the colon 156, for example byapplying a tensile force to the line 140.

The device 10 can deliver agents or drugs to the target site. The distalend of the device 10 can passively rotate, for example if the biologicalnavigation device 10 (e.g., the tip 18) contacts a wall of the colon 156(e.g., the superior wall of the rectum 160), the biological navigationdevice 10 can then deflect from or track to the wall of the colon 156.

FIG. 18 a illustrates that a device 10 having an overtube 24 can bedeployed in a colon. The tip 18 is shown in the descending colon 164 forillustrative purposes. The line 140 (or lines) are not shown forillustrative purposes.

FIG. 18 b illustrates that the actuator 22 can extend, as shown byarrow. The endoscope 12 can be attached to the actuator 22. Theendoscope 12 can advance through the colon as the actuator 22 extends.The endoscope 12 can be slidably adjacent and within the overtube 24. Alubricant can be applied between the endoscope 12 and the overtube 24.

FIG. 18 c illustrates that the actuator 22 can be retracted. Theovertube 24 can slide to advance closer to the distal terminal end ofthe device 10. The method can be repeated to advance the endoscope 12through the colon. The method can be reversed to withdraw the device 10from the colon.

The endoscope 12 can be isolated from exposure to the pressure used toactivate the actuator 22 and/or the anchor 20. The endoscope 12 canextend through the bellows lumen 54 and the support lumen 60.

The device 10 can be used to navigate other sections of the colon (e.g.,ascending, descending, transverse, sigmoid), small intestine, esophagus,stomach, interstitial space, such as within the pleural or peritonealmembrane, blood vessels, or combinations thereof.

The biological navigation device 10 can be manually and/or actuatorcontrolled. Control inputs can be delivered through a manually actuatedcontrollable module, such as a joystick (e.g., for tip control) and/or aseries of linear and rotary potentiometers and switches. The biologicalnavigation device 10 can be programmed to be controlled by voicecommands. The biological navigation device 10 can be controlled by afoot pedal (e.g., for tube extension or translation), and/or acombinational interface (e.g., hand controlled), for example for tipcontrol. The user interface can be attached as part of the biologicalnavigation device 10, and/or the user interface can be a control unitthat is attached by wires to the biological navigation device 10, and/orthe user interface can communicate wirelessly with the remainder of thebiological navigation device 10.

The entire tip 18 can load over the distal terminal end of an endoscope12. The tip 18 can attach to the endoscope 12, the lines 140 can beattached to the line connectors and the device 10 can be delivered intothe biological lumen.

As taught herein, the device 10 can anchor locally and pull theendoscope 12 with a localized pull in the direction of the distalterminal end of the device 10 or endoscope 12 distal pointing end. Themethod can be repeated. Each iteration of the method can advance theendoscope 12 and the distal terminal end of the device 10, for example,from about 3 in. to about 7 in.

Any or all elements of the biological navigation device 10 and/or otherdevices or apparatuses described herein can be made from, for example, asingle or multiple stainless steel alloys, nickel titanium alloys (e.g.,Nitinol), cobalt-chrome alloys (e.g., ELGILOY® from Elgin SpecialtyMetals, Elgin, Ill.; CONICHROME® from Carpenter Metals Corp.,Wyomissing, Pa.), nickel-cobalt alloys (e.g., MP35N® from MagellanIndustrial Trading Company, Inc., Westport, Conn.), molybdenum alloys(e.g., molybdenum TZM alloy, for example as disclosed in InternationalPub. No. WO 03/082363 A2, published 9 Oct. 2003, which is hereinincorporated by reference in its entirety), tungsten-rhenium alloys, forexample, as disclosed in International Pub. No. WO 03/082363, polymerssuch as polyethylene teraphathalate (PET), polyester (e.g., DACRON® fromE. I. Du Pont de Nemours and Company, Wilmington, Del.), polypropylene,aromatic polyesters, such as liquid crystal polymers (e.g., Vectran,from Kuraray Co., Ltd., Tokyo, Japan), ultra high molecular weightpolyethylene (i.e., extended chain, high-modulus or high-performancepolyethylene) fiber and/or yarn (e.g., SPECTRA® Fiber and SPECTRA®Guard, from Honeywell International, Inc., Morris Township, N.J., orDYNEEMA® from Royal DSM N.V., Heerlen, the Netherlands),polytetrafluoroethylene (PTFE), expanded PTFE (ePTFE), polyether ketone(PEK), polyether ether ketone (PEEK), poly ether ketone ketone (PEKK)(also poly aryl ether ketone ketone), nylon, polyether-blockco-polyamide polymers (e.g., PEBAX® from ATOFINA, Paris, France),aliphatic polyether polyurethanes (e.g., TECOFLEX® from ThermedicsPolymer Products, Wilmington, Mass.), polyvinyl chloride (PVC),polyurethane, thermoplastic, fluorinated ethylene propylene (FEP),absorbable or resorbable polymers such as polyglycolic acid (PGA),poly-L-glycolic acid (PLGA), polylactic acid (PLA), poly-L-lactic acid(PLLA), polycaprolactone (PCL), polyethyl acrylate (PEA), polydioxanone(PDS), and pseudo-polyamino tyrosine-based acids, extruded collagen,silicone, zinc, echogenic, radioactive, radiopaque materials, abiomaterial (e.g., cadaver tissue, collagen, allograft, autograft,xenograft) any of the other materials listed herein or combinationsthereof. Examples of radiopaque materials are barium sulfate, zincoxide, titanium, stainless steel, nickel-titanium alloys, tantalum andgold.

The systems, devices, elements and methods disclosed herein can be usedin conjunction or substituted with any of the systems, devices, elementsand methods disclosed in U.S. Pat. Nos. 5,470,632 and 5,333,568; U.S.patent application Ser. No. 12/023,986 filed 31 January 2008 (now U.S.Publication No. 2008/0183038); PCT Application Nos. US 2008/052535 filed30 Jan. 2008 (now PCT Publication No. WO 2008/095046), and US2008/052542filed 30 Jan. 2008 (now PCT Publication No. WO 2008/095052); and U.S.Provisional Application No. 60/887,319, filed 30 Jan. 2007, 60/887,323,filed 30 Jan. 2007, and 60/949,219, filed 11 Jul. 2007, all of which areincorporated herein by reference in their entireties.

The terms colonoscope and endoscope are used for exemplary purposes andcan be any deployable elongated element for use in a body lumen. Anyelements described herein as singular can be pluralized (i.e., anythingdescribed as “one” can be more than one). Any species element of a genuselement can have the characteristics or elements of any other specieselement of that genus. The above-described configurations, elements orcomplete assemblies and methods and their elements for carrying out theinvention, and variations of aspects of the invention can be combinedand modified with each other in any combination.

1. A device for navigation through a biological lumen comprising: apropulsion device comprising an extendable actuator and an anchor,wherein the actuator is distal to the anchor, an endoluminal toolattached to the actuator; and wherein the actuator has an actuator outerwall and an actuator inner wall.
 2. The device of claim 1, wherein theanchor is radially expandable.
 3. The device of claim 1, wherein theanchor is inflatable.
 4. The device of claim 1, wherein the actuatorcomprises a bellows.
 5. The device of claim 1, wherein the actuator hasan inner diameter defining an actuator lumen, and wherein theendoluminal tool is located inside the actuator lumen.
 6. The device ofclaim 1, wherein the actuator comprises a fiber-reinforced laminate. 7.A device for navigation through a biological lumen comprising: anendoluminal tool having an articulatible section; and a bellows attachedto the endoluminal tool distal to the articulatible section.
 8. Thedevice of claim 7, wherein the bellows has an annular configuration. 9.The device of claim 7, wherein the bellows comprises an outer wallcomprising a fiber-reinforced laminate.
 10. The device of claim 7,wherein the bellows comprises a spring.
 11. A device for navigatingthrough a biological lumen comprising: a propulsion device comprising anactuator and an overtube, the actuator distal to the overtube; and anendoluminal tool attached to the actuator.
 12. The device of claim 11,wherein the endoluminal tool is removably attached to the actuator.